My conversation with a contract developer on the show floor this morning confirmed what I’d been hearing: drug companies are searching for new routes of administation for their established drugs. Though there’s been an increase in candidates in Phase I and Phase II studies, fewer candidates are making it to Phase III and commercialization than in the past.
The developer said that respiratory delivery is the vogue, as far as he can see. It makes sense, from a patient’s perspective. Aerosol delivery seems convenient, and it would likely encourage compliance.
Of course, the switch to respiratory delivery (e.g., from a solid oral dose) helps the drug company, too. It allows them extended patent protection for an old drug. Also, regulatory hurdles for a new delivery method are not as intimidating as they are for a brand new drug.
On the other hand, new delivery methods for old drugs can’t be a long-term solution for the industry. Another vendor reminded me that twenty years ago, everyone thought that transdermal delivery would leave everything else in the dust. No more pills to pop or injections to stick in your arm. Slap on a patch, and you’re a happy and healthy camper. Obviously, transdermals haven’t taken over the drug world, but they have supplemented companies’ options.
The vendor drew a parallel between transdermals and respiratory delivery. Although respiratory delivery has advantages for certain therapies, they won’t make other delivery methods obsolete.
For Big Pharma to stay competitive, it must return to innovation. The specialty pharma companies are creating the new drugs, according to the contract developer. Niche companies that are “three men and a molecule,” in his words, are producing the new drugs. Big Pharma has to figure out why these groups are successfully innovating products while they themselves flounder.